A Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Infection

Purpose

This is a Phase II interventional study testing whether treatment with hydroxychloroquine, Vitamin C, Vitamin D, and Zinc can prevent symptoms of COVID-19

Conditions

  • COVID-19
  • Coronavirus Infection
  • Sars-CoV2
  • Corona Virus Infection
  • COVID
  • Coronavirus
  • Coronavirus-19
  • Coronavirus 19

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  1. Informed consent, provided electronically via the EDC, demonstrating the subject understands the procedures required for the study and the purpose of the study 2. Male or female patients 18 years of age or older that are considered to be high-risk individuals. a. High-risk individuals are defined as all health care workers in hospitals, clinics, and emergency rooms, and medical facilities. 3. Subjects must agree to practice at least two highly effective methods of birth control for the duration of the study This includes condoms with spermicide, oral birth control pills, contraceptive implants, intra-uterine devices, or diaphragms. At least one of these must be a barrier method. Subjects not of reproductive potential will be exempt (e.g. post-menopausal, surgically sterilized)

Exclusion Criteria

  1. Refusal to provide informed consent 2. Any previous positive test for COVID-19 by RT-PCR 3. Symptomatic for COVID-19 4. Diarrhea prior to the start of treatment 5. Type I or II diabetes 6. Atherosclerotic Coronary Artery Disease 7. Any contraindication for treatment with hydroxychloroquine including: 1. Hypoglycemia 2. G6PD deficiency 3. Porphyria 4. Anemia 5. Neutropenia 6. Alcoholism 7. Myasthenia Gravis 8. Skeletal muscle disorder 9. Maculopathy 10. Changes in the visual field 11. Liver disease, with ALT/AST > 2.5 upper limit normal and total bilirubin >2.5 upper limit normal 12. Psoriasis 13. Any contraindicated medications found in Appendix 2 8. Any comorbidities which, in the opinion of the investigator, constitute health risk for the subject. 9. Vaccination for SARS-CoV-2

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
This study will focus on medical workers who at elevated risk of COVID-19 due to exposure to positive patients in the Emergency Department or Intensive Care Unit
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Medical Workers 		Medical workers who are exposed to COVID-19 and as such are at higher risk for infection.
  • Drug: Hydroxychloroquine
    Prophylaxis treatment for COVID-19
    Other names:
    • Plaquenil
  • Dietary Supplement: Vitamin C
    Prophylaxis treatment for COVID-19
  • Dietary Supplement: Vitamin D
    Prophylaxis treatment for COVID-19
  • Dietary Supplement: Zinc
    Prophylaxis treatment for COVID-19
Placebo Comparator
Placebo 		Medical workers who are exposed to COVID-19 and as such are at a higher risk for infection
  • Dietary Supplement: Vitamin C
    Prophylaxis treatment for COVID-19
  • Dietary Supplement: Vitamin D
    Prophylaxis treatment for COVID-19
  • Dietary Supplement: Zinc
    Prophylaxis treatment for COVID-19

Recruiting Locations

More Details

NCT ID
NCT04335084
Status
Active, not recruiting
Sponsor
ProgenaBiome

Detailed Description

In this study, subjects will take a regimen of hydroxychloroquine, vitamin C, vitamin D, and Zinc to test if this combination can prevent COVID-19. Treatment with hydroxychlorquine will last 1 day. Treatment with vitamin C, vitamin D, and and zinc will last 12 weeks. The study will last 12 weeks.